BEUDAMED
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    BLADEWORKS MICROKERATOME BLADE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    artegral life

    FDA UDI
    Merz Dental GmbH·D7091993225·anteriors; shade B2; mould UIM

    COUPLANT WARMING DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN DEPUY TIBIAL KNEE INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·March 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011

    DEFIB EPI PATCH

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·August 8, 2014

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015